WK 13: 7 GUIDING PRINCIPLES Flashcards
Evaluation of a diagnostic or therapeutic intervention leading to health improvement while increasing knowledge
Social or scientific value
Study should present with a scientifically sound design, ensuring research outcomes with ACCURATE AND REPRODUCIBLE endpoints
scientific validity
research subjects should be selected through fair inclusion and exclusion criteria
fair subject selection
risks to participants should be minimized while benefits should be maximized
favorable risk/ benefit ratio
evaluation of adherence to ethical standards by full committee of unaffiliated individuals with expertise
independent review
subjects must be accurately INFORMED OF BENEFITS, HARMS AND ALTERNATIVES TO THE PROPOSED RESEARCH
Informed consent
Individuals must be respectfully treated thoughout the study
respect for enrolled participants